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Table 2 Baseline characteristics, by intervention group

From: Daily home fortification with iron as ferrous fumarate versus NaFeEDTA: a randomised, placebo-controlled, non-inferiority trial in Kenyan children

Characteristic Placebo Iron, 3 mg as NaFeEDTA Iron, 12.5 mg as ferrous fumarate
Number (n) 112 112 114
General characteristics
 Sex, male 69 (61.6%) 61 (54.5%) 56 (49.1%)
 Age, months 22.8 (6.8) 23.2 (6.2) 24.9 (6.4)
 Age class    
  12–23 months 61 (54.5%) 57 (50.9%) 44 (38.6%)
  24–36 months 51 (45.5%) 55 (49.1%) 70 (61.4%)
Nutritional markers
 Haemoglobin concentration, g/L 104.4 (13.2) 105.9 (13.3) 104.7 (13.3)
 Anaemia
  Moderate (haemoglobin concentration 70–99.99 g/L) 33 (29.5%) 34 (30.4%) 36 (31.6%)
  Mild (haemoglobin concentration 100–109.99 g/L) 39 (34.8%) 31 (27.7%) 37 (32.5%)
  No anaemia (haemoglobin concentration ≥110 g/L) 40 (35.7%) 47 (42.0%) 41 (36.0%)
 ZPP:haem ratio, μmol:mola    
  In whole blood 170 (119; 305) 172 (102; 260) 196 (137; 283)
  In erythrocytes 130 (84; 301) 141 (76; 223) 160 (101; 246)
 Plasma ferritin concentration, μg/La,b 37.7 (17.3; 74.0) 31.4 (16.0; 56.6) 36.9 (17.6; 68.8)
 Iron statusb
  Deficient (plasma ferritin concentration <12 μg/L) 17 (15.2%) 20 (18.3%) 20 (17.9%)
  Replete (plasma ferritin concentration ≥12 μg/L in the absence of inflammation) 26 (23.2%) 32 (29.4%) 19 (17.0%)
  Uncertain (plasma ferritin concentration ≥12 μg/L in the presence of inflammation) 69 (61.6%) 57 (52.3%) 73 (65.2%)
 Iron deficiency, based on adjusted ferritin concentrationsb,c 52.7% (59/112) 57.8% (63/109) 49.1% (55/112)
 Plasma soluble transferrin receptor concentration, mg/La 2.41 (1.75; 3.46) 2.39 (1.82; 3.16) 2.60 (1.93; 3.41)
 Plasma albumin concentration, g/L 34.6 (3.9) 35.0 (3.5) 34.7 (4.1)
 Vitamin B12 concentration, pmol/L 391 (291; 557) 409 (311; 569) 401 (315; 554)
Infection and inflammation markers
 Plasma C-reactive protein concentration, mg/La 2.5 (0.7; 7.6) 2.5 (0.6; 7.8) 4.5 (1.3; 11.0)
 Plasma α 1-acid glycoprotein concentration, g/La 1.20 (0.90; 1.57) 1.08 (0.81; 1.47) 1.17 (0.97; 1.63)
 Inflammation
  Plasma C-reactive protein concentration >5 mg/L 40 (35.7%) 35 (31.3%) 53 (46.5%)
  Plasma α 1-acid glycoprotein concentration >1 g/L 71 (63.4%) 63 (56.3%) 81 (71.1%)
  Plasma C-reactive protein concentration >5 mg/L or plasma α 1-acid glycoprotein concentration >1 g/L 77 (68.8%) 65 (58%) 84 (73.7%)
Plasmodium antigenaemia, by rapid dipstick testsd
  P. falciparum (either HRP2 or P. falciparum-specific pLDH) 39 (35.1%) 40 (36.0%) 43 (38.1%)
  Plasmodium species other than P. falciparum (pLDH specific for P. malariae, P. ovale or P. vivax)e 1 (0.9%) 2 (1.8%) 0
  Any Plasmodium species 39 (35.1%) 41 (36.9%) 43 (38.1%)
 Blood smear tests, by microscopy    
  Asexual or sexual forms of P. falciparum 47 (41.9%) 49 (43.8%) 55 (48.2%)
  Asexual forms of both P. falciparum and human Plasmodium spp. other than P. falciparum (i.e. P. malariae, P. ovale or P. vivax) 2 (1.8) 1 (0.8) 2 (1.8)
  Asexual parasite density for P. falciparum, μ/La 757 (172; 3972) 3340 (297; 20,023) 1048 (207; 6820)
   Low (<1000 μ/L) 17 (15.2%) 9 (8.0%) 19 (16.7%)
   Medium (1000–9999 μ/L) 12 (10.7%) 8 (7.1%) 15 (13.2%)
   High (≥10,000 μ/L) 3 (2.7%) 7 (6.3%) 5 (4.4%)
  Gametocyte density, μ/La 326 (49; 732) 82 (37; 120) 1126 (57; 2679)
Anthropometric markers
 Body height, cm 80.9 (5.9) 82.1 (5.7) 82.4 (5.1)
 Body weight, kg 10.6 (1.8) 10.8 (2.0) 10.9 (1.7)
 Height-for-age z-score, SD –1.42 (1.47) –1.15 (1.43) –1.43 (1.31)
 Weight-for-height z-score, SD –0.10 (1.05) –0.16 (1.07) –0.14 (0.93)
 Weight-for-age z-score, SD –0.81 (1.18) –0.71 (1.22) –0.86 (1.09)
 Stunted (height-for-age z-score < –2 SD) 34 (30.4%) 31 (27.7%) 37 (32.5%)
 Wasted (weight-for-height z-score < –2 SD) 3 (2.7%) 5 (4.5%) 2 (1.8%)
 Underweight (weight-for-age z-score < –2 SD) 19 (17.0%) 12 (10.7%) 15 (13.2%)
  1. Values indicate n (%), mean (SD) or amedian (25th and 75th percentiles). HRP2 histidine-rich protein-2, pLDH P. falciparum-specific lactate dehydrogenase
  2. bDue to missing values for ferritin concentrations in 5 children, n was 112, 109 and 112 for groups that received placebo, NaFeEDTA and ferrous fumarate, respectively; cbased on ferritin concentrations adjusted for inflammation by linear regression (see text)
  3. dDue to missing values in 3 children, n was 111, 111 and 113 for groups that received placebo, NaFeEDTA and ferrous fumarate, respectively
  4. eOne child in placebo group and 1 child in NaFeEDTA group with antigenaemia due to P. malariae or P. ovale or P. vivax also had antigenaemia to P. falciparum (mixed infection)